Robotic Platform for Brain Cancer

Overseen By Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-center, single-arm observational study in which the investigators aim to develop an advanced motion control system for head stabilization in patients undergoing whole brain radiation therapy.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Freedom Pursuit Robotic Platform treatment for brain cancer?

Research on frameless image-guided robotic radiosurgery, similar to the Freedom Pursuit Robotic Platform, shows it is safe and effective for treating brain metastases, with a high local control rate of 95.2% after one year. This suggests that robotic platforms can accurately target brain tumors, potentially benefiting brain cancer treatment. ^{1 2 3 4 5}

How is the Freedom Pursuit Robotic Platform treatment different from other brain cancer treatments?

The Freedom Pursuit Robotic Platform is unique because it uses a robotic system to automatically detect and clean up brain tumor residues after conventional surgery, potentially improving the completeness of tumor removal and enhancing patient outcomes. ^{6 7 8 9 10}

Research Team

Michelle Alonso-Basanta, MD, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for patients with brain metastases or brain cancer who are undergoing whole brain radiation therapy. Specific eligibility criteria details are not provided, so it's best to contact the study team for more information.

Inclusion Criteria

Participants must sign the informed consent form

I am 18 or older and receiving whole brain radiation therapy.

Exclusion Criteria

All patients not meeting the above inclusion criteria will not be considered for this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo whole brain radiation therapy with real-time head stabilization using a robotic support platform

24 months

Follow-up

Participants are monitored for safety and effectiveness after radiation therapy

4 weeks

Treatment Details

Interventions

• Freedom Pursuit Robotic Platform

Trial Overview The trial is testing an advanced motion control system called the Freedom Pursuit Robotic Platform designed to stabilize a patient's head during whole brain radiation therapy. It's observational, meaning they're just watching and recording what happens.

Participant Groups

Group I: Head Stabilization Experimental Treatment 1 Intervention

Real-time patient head stabilization during radiation therapy will be performed using a specially designed patient mask and head holder that are connected to a robotic patient support platform (Freedom Pursuit Robotic Platform, CDR Systems, Canada) that will use real-time 3D surface data from the AlignRT system (3D surface imager) as an input and will perform small sub-millimeter corrections.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Relationship between pattern of enhancement and local control of brain metastases after radiosurgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Feasibility, safety, and outcome of frameless image-guided robotic radiosurgery for brain metastases. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Radiosurgery for brain metastases: relationship of dose and pattern of enhancement to local control. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cancer Moonshot Data and Technology Team: Enabling a National Learning Healthcare System for Cancer to Unleash the Power of Data. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Frameless LINAC-based stereotactic radiation therapy to brain metastasis resection cavity without whole-brain radiation therapy: A systematic review. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Semi-autonomous image-guided brain tumour resection using an integrated robotic system: A bench-top study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Neurosurgical robot Minerva: first results and current developments. [2006]

8. United States pubmed.ncbi.nlm.nih.gov

WE-G-213CD-06: Implementation of Real-Time Tumor Tracking Using Robotic Couch. [2019]

9. France pubmed.ncbi.nlm.nih.gov

[CyberKnife robotic stereotactic radiotherapy: technical aspects and medical indications]. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Towards frameless maskless SRS through real-time 6DoF robotic motion compensation. [2018]